Kornimate/medical-research-clean huggingface dataset:
evaluating a mobile phone intervention

Conditions: Depression; Rumination - Thoughts

Summary: this clinical trial intends to study the efficacy of a mobile phone delivered intervention in reducing depression-related rumination.

here we propose to test a novel intervention to help individuals manage their depressive rumination. the intervention is based on a just-in-time, adaptive-intervention (jitai) design. a jitai is "an intervention designed to address the dynamically changing needs of individuals via the provision of the type/amount of support needed, at the right time, and only when needed ." this study is also to address one major concern regarding designing jitai interventions: the burden on participants in having to be engaged with the intervention through diaries, self-reports, and other forms of assessment procedures daily. to reduce this burden, we first pilot test an interactive narrative form. an interactive narrative is an essential form of storytelling that involves certain interactive features such that audiences or readers of the story can have the feeling that they are actively engaging in certain forms of interactions with the story characters. to test the efficacy of such an intervention, there will be a one-month three-arm clinical control trial to reduce depressive rumination. there are three conditions: a jitai interactive narrative condition, a non-narrative jtiai condition, and a wait-list control condition. this study could contribute to our knowledge in designing more effective interventions in curbing depression using mobile technology. it can also advance our theoretical knowledge of the role of interactive narratives in reducing user burden in mobile health.

Eligibility criteria:
inclusion criteria: * participants who have a current self-reported clinical diagnosis of being depressed ( mild to moderate depression and major depressive disorder) * participants should be 18 or older. * participants should have a working smartphone and daily access to the internet. exclusion criteria: -participants who do not have regular access to the internet and a smart phones will be excluded.
mnpr-101-dfo*-89zr expanded access program (eap) for patients with solid tumor cancer

Conditions: Cancer; Solid Tumor; Solid Tumor, Adult

Summary: the purpose of this expanded access program (eap) is to allow use of the investigational imaging agent, mnpr-101-dfo\*-89zr, with positron emission tomography/computed tomography (pet/ct) imaging, to non-invasively detect the presence of urokinase plasminogen activator receptor (upar) binding in solid tumors. upar binding is higher in tumors compared to normal tissue in some cancers.

imaging agent mnpr-101-dfo\*-89zr will be dosed to adult patients diagnosed with solid tumor cancer followed 3 to 5 days later by pet/ct imaging. the result will determine if there is sufficient upar binding, as assessed by the investigator, to support administration of the companion intervention mnpr-101-pcta-177lu in a separate expanded access program (eap ist-00cb). the safety of mnpr-101-dfo\*-89zr will be evaluated as will the amount of radioactivity present in blood samples.

Eligibility criteria:
key inclusion criteria: * histologically or cytologically confirmed locally advanced or metastatic solid tumor cancer that is refractory to existing therapy(ies) known to provide clinical benefit, or for which no standard treatment is available, or is contraindicated * ability to understand and willingness to sign a written informed consent document key exclusion criteria: * continuing ≥ grade 3 adverse reactions from prior systemic therapy (common terminology criteria for adverse events \[ctcae\] version 5.0) * prior treatment with any radiopharmaceutical or investigational agents within 4 weeks or 5 half-lives, whichever is longer, prior to administration of mnpr-101-dfo\*-89zr * evidence of impaired organ function, particularly bone marrow, liver, kidney, or heart, according to specific test parameters * presence of other serious, non-malignant diseases or any other condition that, in the opinion of the investigator, could interfere with the objectives of the study, participant safety, or compliance.

Keywords: solid tumor pet/ct urokinase plasminogen activator receptor upar zirconium-89 imaging positron emission tomography/computed tomography mnpr-101-dfo*-89zr upar-positive urokinase plasminogen activator receptor-positive eap ist-00cb antibody radionuclide conjugate monoclonal antibody radionuclide conjugate solid tumor imaging
comparison of the incidence of inadequate epidural analgesia between protocol based and current practice

Conditions: Epidural Analgesia; Postoperative Pain

Summary: epidural analgesia is the recommended analgesic technique in patients having surgery with severe postoperative pain such as thoracic and upper abdominal surgery. however, from the previous study, the incidence of inadequate pain control in patients receiving epidural analgesia is very high 48.6% in our hospital.

a high incidence of inadequate epidural analgesia may result from variety of epidural techniques and epidural drug administrations. the protocol based practice has been developed from acute pain service which founded for more than 10 years. by using protocol based practice, the investigators believed that the incidence of inadequate epidural analgesia will be less compared with the current practice.

Eligibility criteria:
inclusion criteria: * all patients age ≥ 18 years old undergo surgery with epidural catheter insertion at siriraj hospital. exclusion criteria: * coagulopathy * allergy to study drugs: local anesthetics and opioids * history of chronic pain

Keywords: epidural analgesia postoperative pain
lifestyle enriching activities for research in neuroscience intervention trial: learnit study

Conditions: Aging; Cognitive Ability, General

Summary: the purpose of this study is to examine the effects of modifiable lifestyle factors including exercise and healthy living on brain health. the investigators will compare 2 types of interventions, moderate aerobic walking vs. healthy living education, over 6 months to evaluate changes in brain health, cognition, and physical function in older adults with cognitive concerns.

cognitive decline in older adults is a major public health issue. the cost of caring for older adults with substantial cognitive impairment, like those with alzheimer's disease in the us is approximately $200 billion a year, causing major societal, economic, and caregiving burden. despite great advances towards diagnosing these problems, the discovery of effective treatments has been minimal. exploring non-pharmacological interventions, such as exercise and healthy living, have gained momentum. these promising, modifiable lifestyle interventions have the potential for delaying disease onset and slowing decline in cognition. however, the therapeutic effect of lifestyle interventions in patients with mild cognitive impairment, a prime intervention period for treatment, is not well understood. therefore, in this study, the investigators will examine brain, body, and cognitive changes in older adults who engage in moderate-aerobic walking or healthy living education.

Eligibility criteria:
inclusion criteria: 1. male or female 2. english-speaking 3. 55-80 years old 4. exhibits sedentary behavior 5. objective cognitive impairment 6. mini-mental state exam score \> 26 7. perform at least 1 standard deviations below normative values on cognitive tests 8. absence of dementia 9. ability to complete both mri and pet scans 10. physically capable of completing health programs exclusion criteria: 1. baseline dementia 2. history of a neurological disorder 3. current psychiatric illness 4. head trauma with a loss of consciousness \> 10 minutes 5. severe sensory deficits 6. substance abuse 7. depression (gds \< 8 of 15) 8. inability to perform intervention (e.g., inability to walk without assistance) 9. contraindications to mri scan (e.g., pacemaker)

Keywords: alzheimer's disease mild cognitive impairment brain imaging
microbiological diagnosis of infectious uveitis to pathogenic fastidious germs

Conditions: Uveitis

Summary: our research project is to use a new microbiological diagnostic strategy of uveitis, allowing detection of the fastidious pathogens of infectious uveitis who are not diagnosed by laboratory methods used in diagnostic routine. this new diagnostic strategy is to automatically detect the presence of a pathogen fastidious in cell culture using the same patient's serum to reveal a positive culture, based on the assumption that this serum contains antibodies specific pathogen tedious. finally, the main purpose of this study is to improve the etiological diagnosis of uveitis by establishing a new diagnostic strategy.

the mediterranean infection microbiology laboratory is the national reference laboratory for the diagnosis of infectious uveitis. the essential problem of the uveitis is the etiological diagnosis since currently in 60% of cases no etiological diagnosis is brought out despite the deployment of routine diagnostic tests. the prognosis of the uveitis is generally good but 15% approximately of uveitis are evolving on a chronic mode which decreased faster than the visual acuity of the eye reached that can lead to blindness in bilateral cases of uveitis. different works of the literature identified a few pathogenic microorganisms, viruses and bacteria as being responsible for uveitis, including within the particular framework of the endophtalmies. recent work allowed to highlight the place of fastidious bacteria (bartonella spp., tropheryma whipplei, rickettsia spp., coxiella burnetii, borrelia spp.) in these uveitis. despite all his investigations, is estimated that 20-30% of uveitis likely to be of infectious origin are not documented by the methods used in routine. our research project is to use a new microbiological diagnostic strategy of uveitis, allowing detection of the fastidious pathogens of infectious uveitis who are not diagnosed by laboratory methods used in diagnostic routine. this new diagnostic strategy is to automatically detect the presence of a pathogen fastidious in cell culture using the same patient's serum to reveal a positive culture, based on the assumption that this serum contains antibodies specific pathogen tedious.

Eligibility criteria:
inclusion criteria: \* patient is more than 18 years old. * patient with a prescription of a microbiologic diagnostic of uveitis * patient who do not declined to have his medical records reviewed for research * patient with health insurance exclusion criteria: \* minor patient ( age \<18 years) (l. 1121-7 ) . * pregnant woman , parturient or nursing (l. 1121-5 ) . * patient major under guardianship (l. 1121-8 ) . * patient vital in emergency. * patient refusing to sign the informed consent form . * patient deprived of liberty under court order (l. 1121-6 ) .
phase ii two-step radioimmunotherapy clinical study in medullary thyroid carcinoma

Conditions: Thyroid Neoplasms

Summary: phase ii clinical trial assessing efficacy and toxicity of pretargeted radioimmunotherapy using anti-ceaxanti-dtpa bispecific antibody and di-dtpa-131i peptide in patients with reccurrence of medullary thyroid carcinoma (abnormal calcitonin level and biomarkers doubling time lower than 5 years)


Eligibility criteria:
inclusion criteria: * 18 -75 years * karnofsky ≥ 70% * histological diagnosis of medullary thyroid carcinoma * calcitonin serum level ê 100 pg/ml and calcitonin or cea doubling time £ 5 years * normal liver and renal functions * granulocytes ≥ 1500/mm3 and platelets ≥ 150 000/mm3 * no immunization * consent form signed

Keywords: recurrence of medullary thyroid carcinoma: abnormal calcitonin level and biomarkers doubling time lower than 5 years after initial surgery
linagliptin response to ogtt in prediabetes and type 2 diabetes mellitus

Conditions: PreDiabetes; Type 2 Diabetes

Summary: there are studies that suggest glycemic response to incretin-based therapies differs between asians and caucasians, whereby asians have better response compared to caucasians. hence, the therapeutic response could also be augmented by difference in incretin system among various ethnicities. this study is carried out to study the effect of dipeptidyl-peptidase iv (dppiv) inhibitors in prediabetes and t2dm patients who have different levels of glp-1 and to determine the effect on glycemic profiles, insulin resistance/sensitivity, beta-cell functon.

a 12-week, open-label, single treatment study using linagliptin is conducted in 28 prediabetes and 22 t2dm subjects who are divided into low and high fasting glp-1 groups. prediabetes are recruited from ogtt screening. type 2 diabetes patients are recruited from specialised diabetes clinic and routine follow-up. a 75-g oral glucose tolerance test (ogtt) is performed at week 0 and 12. venous blood samples were drawn at times 0 (before initiation of ogtt), 30, 60, 90, 120 min from the indwelling catheter for measurement of glucose and insulin.all prediabetes and t2dm subjects receive linagliptin 5mg once daily for a duration of 12 weeks.

Eligibility criteria:
inclusion criteria: * prediabetes diagnosed from ogtt and t2dm subjects * hba1c \> 6.5% and \<10% * subjects not receiving any glucose-lowering medication or just receiving metformin and/or sulphonylureas and/or alpha-glucosidase inhibitors on stable dose for at least 3 months. * subjects who are willing to participate and sign the informed consent form exclusion criteria: * subjects with ketoacidosis or lactic acidosis, overt diabetes, another disease causing secondary glucose intolerance, congestive heart failure (new york heart association class iii or iv), myocardial infarction, stroke or ischemic attacks in past 6 months, uncontrolled severe hypertension, active liver conditions such as cirrhosis or hepatitis \[elevation in liver enzymes to higher activities than double the respective normal value\], moderate to severe renal insufficiency, pregnancy, breast-feeding * patients receiving insulin, glp-1 receptor agonists, dipeptidyl peptidase iv inhibitors or glucose-lowering medications other than metformin /sulphonylureas /alpha-glucosidase inhibitors as treatment. * subjects with uncontrolled blood glucose hba1c\>10% * subjects who plan to move out of state / country

Keywords: glucagon-like peptide 1 dipeptidyl peptidase inhibitor oral glucose tolerance test prediabetes type 2 diabetes
etol-elderly study of the efficiency of the innovative food supplement in elderly adults

Conditions: Vitamin d Deficiency; Vitamin B 12 Deficiency; Protein Deficiency

Summary: the aim of this pilot study is to conduct a study on geriatric population in slovenia (non-users of dietary supplements/medicines with vitamine d, vitamin b12 and protein) and assess deficiency of selected nutrients, and to investigate the efficiency of the innovative food supplement prototype in improving nutritional status of elderly adults.

the main objective is to show that in the geriatric population regular use of investigation food supplement would improve nutritional status. the study should provide answers to the following main questions: (1) is regular use of investigated product beneficial for improving serum vitamin d levels in elderly population? (2) is regular use of investigated product beneficial for increasing daily protein intake in elderly population? (3) is regular use of investigated product beneficial for improving vitamin b12 status in elderly population?

Eligibility criteria:
inclusion criteria: * subject informed consent form (icf) is singed * aged at least 65 at the time of the signature of icf * a body mass index lower than 32 kg/m2 * willing to avoid a consumption supplementation with protein, vitamin d and vitamin b12 during the study * willing to follow all study procedures, including attending all site visits (including blood sampling) and keeping a diary for using the product and six 24-hour dietary records (3x pre-intervention, 3x during last week of the intervention) exclusion criteria: * medical treatment with vitamin d and/or vitamin b12 * supplementation with protein, vitamin d and/or vitamin b12 during least 2 months * known drug and/or alcohol abuse * known lactose/gluten intolerances/food allergies * inadequate veins (in the opinion of the investigator) or known contraindication for venous blood withdrawal * have chronic bowel disease (ulcerative colitis, chron's disease, stomach or duodenal ulcer, chronic inflammation of the stomach or duodenum) * have acute gastrointestinal infection with vomiting and / or diarrhea * have planned general anaesthesia or colonoscopy at the time of the study * have malabsorption syndrome * less than 5 years after treatment for gastrointestinal cancer (stomach, duodenum or colon) * have stomach or bowel resection * do not have neat and functional teeth * take regular or occasional laxative products * use antacids (rupurut / rutacid / talcit) * mental incapacity that precludes adequate understanding or cooperation * participation in another investigational study
pharmacist-led continuous glucose monitoring

Conditions: Type 2 Diabetes

Summary: this is a pilot study. the goal of this prospective cohort study is to determine impact of pharmacist-led continuous glucose monitoring on glycemic control and health behavior change in people with type 2 diabetes. the main questions it aims to answer are: 1. to assess change in hemoglobin a1c in people with type 2 diabetes using continuous glucose monitoring under a pharmacist-led approach as compared to a pharmacist-led approach utilizing no continuous glucose monitoring (only self-monitoring blood glucose with a glucometer). 2. to assess change in continuous glucose monitoring-derived glycemic outcomes among the pharmacist-led continuous glucose monitoring cohort (intervention group) 3. to assess change in health behavior among the pharmacist-led continuous glucose monitoring cohort (intervention group)


Eligibility criteria:
inclusion criteria: * type 2 diabetes * hemoglobin a1c ≥ 8% * compatible smartphone with freestyle libre 2 continuous glucose monitoring system * current use and access to a glucometer for self-monitoring of blood glucose exclusion criteria: * any continuous glucose monitor use within 6 months prior to study enrollment * pregnant and planning to become pregnant during study time frame * history of hypoglycemia requiring third party assistance * history of diabetic ketoacidosis or hyperosmolar hyperglycemic state within 6 months prior to study enrollment * known allergy to medical grade adhesives * current use of systemic steroids for any medical condition * current use of dialysis

Keywords: type 2 diabetes endocrine disorders continuous glucose monitor pharmacist
a randomized, double-blind, active control, parallel group, titration, multicenter study to evaluate the efficacy and safety of fimasartan

Conditions: Chronic Kidney Disease

Summary: the purpose of this study is to evaluate the efficacy and safety of fimasartan in patients with hypertensive diabetic chronic kidney disease.

the randomized subjects will take the investigational product (fimasartan or losartan) corresponding to each treatment group for 24 weeks. after that, all subjects will take fimasartan for additional 120 weeks in an open-label, 2-parallel group study conducted with 2 groups in accordance with the blood pressure control criteria.

Eligibility criteria:
inclusion criteria: 1. male and female adults aged 19 years or older 2. blood pressure: mean blood pressure is as below at screening. * for treatment-naïve patients: 140 mmhg ≤ sbp \< 180 mmhg and dbp \< 110 mmhg * for patients who are taking acei or arb: 130 mmhg ≤ sbp \< 180 mmhg and dbp \< 110 mmhg 3. egfr: ≥ 30 ml/min/1.73 m2 within the past 6 months 4. albuminuria (acr) excretion volume: meets one or more of the following conditions * acr \> 300 mg/g (or mg/day) within the past 12 months * there are at least two results of 30 ≤ acr ≤ 300 mg/g (or mg/day) within the past 12 months and the interval between the two test is at least 12 weeks. 5. patients with diabetes 6. voluntarily provided a written consent to participate 7. able to understand this study, be cooperative in the execution of the study exclusion criteria: 1. severe hypertension with mean sbp ≥ 180 mmhg or dbp ≥ 110 mmhg 2. orthostatic hypotension with symptoms 3. insulin dependent diabetes mellitus or uncontrolled diabetes mellitus 4. patients on dialysis, patients with clinically significant cardiac and hepatic diseases
study of dalbavancin drug levels achieved in hospitalized adolescents who are receiving antibiotic therapy for bacterial infections

Conditions: Bacterial Infections

Summary: adolescent subjects hospitalized for the treatment of bacterial infections will be given 1 gram of dalbavancin through their veins and levels of dalbavancin in blood and urine will be measured at different time points. safety labs will also be checked on a regular basis to assess the safety of dalbavancin.


Eligibility criteria:
inclusion criteria: * 12 to 17 year old adolescents hospitalized for the treatment of bacterial infections. exclusion criteria: * patients being treated with vancomycin. * patients with liver and kidney failure. * pregnant female subjects.

Keywords: dalbavancin adolescent subjects
mindfulness engaged neurostimulation for depression

Conditions: Depression; Treatment Resistant Depression; Major Depressive Disorder; Depressive Disorder

Summary: repetitive transcranial magnetic stimulation (rtms) is an fda-approved therapy for treatment resistant depression (trd) that involves brief magnetic stimulation pulses on the dorsolateral prefrontal cortex (dlpfc) brain region. but studies of rtms alone show remission rates of \~30%. additionally, rtms has not been shown to improve cognitive functioning that may be an independent factor predicting treatment success. this study will develop a novel multimodal treatment, which combines intermittent theta burst stimulation (itbs) - a type of rtms with digital mindfulness training to engage brain plasticity, enhance cognition and alleviate depression symptoms in individuals with trd.

this study aims to develop a novel multimodal treatment for treatment resistant depression (trd), which combines intermittent theta burst stimulation (itbs), a type of fda-approved rtms protocol, with digital mindfulness training. we propose that this multimodal treatment will suppress posterior default mode network (pdmn) brain activity as measured with electroencephalography (primary outcome and neural target), as well as enhance cognition and alleviate depression symptoms in patients with trd. the study will determine the optimal dose required for neural target engagement by the multimodal itbs + digital mindfulness training relative to an active control training combined with itbs.

Eligibility criteria:
inclusion criteria: * diagnosis of major depressive episode (mde, in accordance with the diagnostic and statistical manual of mental disorders 5th edition (dsm-5), in the context of unipolar major depressive disorder. * at least one failed antidepressant medication trial at level 3 in the antidepressant treatment history form: short form (athf-sf) classification. * montgomery-åsberg depression rating scale (madrs) score \>19 (moderate - severe depression). * no increase or initiation of new antidepressant therapy in the four weeks prior to screening. * demonstrated capacity to give informed consent. exclusion criteria: * inability to provide informed consent. * medically unstable patients. * concomitant neurological disorder or a history of a seizure disorder. * exhibiting current suicidal behavior rating on the columbia suicide severity rating scale (c-ssrs) * patients who are pregnant or breastfeeding. * any psychotic disorder or current active psychotic symptoms. * patients who have intracranial implants, other medical device or condition deemed unsafe for tms. * contraindication to mri scanning.

Keywords: rtms mindfulness depression